Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies

With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG). The following aims will be pursued: 1. to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods; 2. to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure/interictal epileptic discharges; distribution for the development of personalized seizure action plan; 3. to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes. The investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments. The potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.

NCT Number	NCT06855901
Lead Sponsor	Azienda Ospedaliero-Universitaria di Modena Collaborators: Azienda Ospedaliera Universitaria Federico II (AOU Federico II), Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy, Ospedale Pediatrico Bambino Gesù, Rome (IT)
Conditions	Epilepsies, Epilepsies, Focal, Epileptic Encephalopathy
Enrollment	30 participants
Start Date	2024-01-17
Primary Completion	2026-05-31 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-04